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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K260686

510(k) cleared

Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter

Zylox Medtech Co., Ltd. · Oct 22, 2026 · K260686

FDA cleared the Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter from Zylox Medtech Co., Ltd. on Oct 22, 2026 under K260686, a traditional 510(k). The device falls under product code PNO, Catheter, Percutaneous, Cutting/Scoring, regulated at 21 CFR 870.1250 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Mar 3, 2026. The decision came 233 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zylox Medtech Co., Ltd. has one other decision in the tracker over the last 12 months: K260416 (ZYLOX Hippo PTA Balloon Dilatation Catheter).

Questions & Answers

What did FDA clear under K260686?

K260686 is the FDA 510(k) for Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter, submitted by Zylox Medtech Co., Ltd.. FDA's decision date was Oct 22, 2026, under product code PNO (Catheter, Percutaneous, Cutting/Scoring).

Who makes the Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter?

Zylox Medtech Co., Ltd., based in Hangzhou, is the applicant of record for K260686.

How long did the K260686 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on Oct 22, 2026, 233 days later.

← All decisions in October 2026

Sources